Consent and enrollment process: achieving high enrollment rates for obstetric research.

Area of Science:

• Healthcare research methodology
• Clinical trial management
• Patient recruitment strategies

Background:

• Patient consent and enrollment present significant challenges in healthcare research, particularly for vulnerable populations such as pregnant women.
• While barriers to participation are known, effective strategies for consistent improvement in consent and enrollment rates remain underexplored.

Purpose of the Study:

• To develop, design, and implement a patient consent and enrollment initiative.
• To identify specific strategies that effectively enhance patient participation in research studies.

Main Methods:

• A case study approach was employed to evaluate a consent and enrollment strategy.
• Data collection involved practitioner interviews, focus groups, and review of study documentation over a three-year period.
• The initiative focused on optimizing the participation of mothers delivering infants during the study period.

Main Results:

• A total of 19,236 mothers were enrolled, achieving an 85% enrollment rate across five study sites.
• Enrollment rates demonstrated improvement over the study duration.
• Key factors contributing to improved enrollment included increased nursing engagement in recruitment, site-specific adaptations, and enhanced patient education.

Conclusions:

• A multifaceted consent and enrollment program, characterized by active nursing involvement and a rapid feedback mechanism, shows considerable promise for improving participation.
• The study highlights the critical role of nursing staff in the successful implementation of research initiatives.
• Continuous feedback and adaptable strategies are essential for optimizing patient enrollment in clinical research.